EP0667133B1 - Valve d'implant percutané pour vaisseaux sanguins - Google Patents

Valve d'implant percutané pour vaisseaux sanguins Download PDF

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Publication number
EP0667133B1
EP0667133B1 EP93830500A EP93830500A EP0667133B1 EP 0667133 B1 EP0667133 B1 EP 0667133B1 EP 93830500 A EP93830500 A EP 93830500A EP 93830500 A EP93830500 A EP 93830500A EP 0667133 B1 EP0667133 B1 EP 0667133B1
Authority
EP
European Patent Office
Prior art keywords
valve
blood vessel
turns
catheter
blood
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP93830500A
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German (de)
English (en)
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EP0667133A1 (fr
Inventor
Sante Camilli
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Individual
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to DE69330003T priority Critical patent/DE69330003T2/de
Priority to ES93830500T priority patent/ES2157918T3/es
Priority to EP93830500A priority patent/EP0667133B1/fr
Priority to AT93830500T priority patent/ATE199490T1/de
Priority to US08/300,133 priority patent/US5607465A/en
Publication of EP0667133A1 publication Critical patent/EP0667133A1/fr
Application granted granted Critical
Publication of EP0667133B1 publication Critical patent/EP0667133B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2475—Venous valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath

Definitions

  • the present invention relates to the valves for the use in living bodies.
  • the artificial valves for the use in a blood vessel, internal to the blood vessel itself, in contact with the blood stream passing therethrough.
  • the present invention relates to the valves of the said type, which are intended to operate inside a vein, as well as endowed with a monocusp valving element.
  • valve As used herein, by “valving element”, or “valving means”, the means is meant, mounted on the support or the valve, whereby the control of the blood flow is achieved.
  • valve prosthesis for implantation in the body which comprises a stent made from an expandable cylinder shaped thread structure comprising spaced apices.
  • the valve is elastically collapsible and is mounted on the stent as the commissural points of the valve are secured to the projecting apices.
  • the valve prosthesis can be compressed around balloon means of a balloon catheter and be inserted into a channel, for instance the aorta.
  • Lane's valve isn't, strictly speaking, a valve, but only an outer prosthesis whereinto a vein segment is intussuscepted to form a venous valve, in which the blood doesn't come in contact with the prosthesis itself. It is not commercially available, it is not implantable at a distance.
  • Taheri's valve has an annular support which has a tendency to go out of alignement when implanted in a vein during low endoluminal pressure stages and when the vein is compressed from the outside.
  • Its valving means are two leaflets, which aren't protected by the annular support during their motion of opening and closing from the collapse of the venous wall during low endoluminal pressure stages and when the vein is compressed from the outside. It isn't commercially available, it isn't implantable at a distance.
  • Quijano et al. 's valve is a biological valve, that is to say it is entirely made from animal tissues, and is endowed with a two-leaflet valving means. It isn't commercially available, it isn't implantable at a distance.
  • valves Various types of artificial valves made for being used in heart (heart valves) are known in the operative art: these valves are not applicable in veins. In fact, they are intrinsically different from venous valves for the structure or the size or the materials or the characteristics of mechanical strength or the forces necessary for their operation or the way of insertion or the method for fixing them in the desired site.
  • venous valves for the structure or the size or the materials or the characteristics of mechanical strength or the forces necessary for their operation or the way of insertion or the method for fixing them in the desired site.
  • veins there are low pressures and low flows; moreover, the diametres of the veins that have valvular incompetence are small and these veins are easily compressible from outside under various conditions.
  • Such a valve has only one valving element, as this is made up of the said plate, which is a monocusp; so thrombogenesis is substantially reduced and the valve is able to operate reliably.
  • the main object of the present invention is to provide a valve for the use in blood vessels, which is implantable at a distance.
  • Another object of the present invention is to provide a valve for the use in blood vessels, which is substantially less thrombogenic than the known ones.
  • the advantages offered by the present invention are mainly that it provides a valve for the use in blood vessels which is implantable at a distance, which was never made before.
  • This advantage is achieved by virtue of the cage structure of the wire support, which can be so made, as to be folded in such a way as to free its three-dimensional space occupation. After introducing at a distance, percutaneously, the valve into the desired site, the valve itself can be restored to its original three-dimensional configuration.
  • the present invention affords a valve which is substantially less thrombogenic than the known ones: indeed, its support doesn't develop bidimensionally, still by virtue of its cage structure; then it offers a very restricted extension for the formation of thrombi.
  • the present invention relates to a valve as specified in claim 1.
  • said sail valving element is endowed with a check line fixed to said central turn. in order to prevent the valving element itself from stopping in a don't care condition.
  • said sail valving element is endowed with a control shaft incorporated in itself, again to prevent the valving element from stopping in a don't care position.
  • valve of the present invention is endowed with hooking means for its fixation to a blood vessel wall.
  • a catheter to be used with the valve is endowed at its distal end with a capsule for transporting, means for grasping and loading into said capsule as well as for releasing in a desired site a valve according to the present invention.
  • such a catheter comprises an inflatable balloon to obtain the occlusion of a blood vessel.
  • the support or valve body is made up of a wire mesh 1, in a plastic material or in a biocompatible metallic alloy, such as the nickel (Ni) and cobalt (Co) alloy Phynox ® , eventually treated with antithrombogenic processes, having a circular cross section, with a diametre of about 0.3 millimetres, flexible, elastic and plastic, shaped and twisted so as to form three turns, whereof two end ones 6, 6', substantially circular and lying on the periphery of the bases of a right cylinder, and a central one 5, with an ellipse-like contour substantially lying on a plane at about 130° relative to the said circle-like turns 6, 6'.
  • a biocompatible metallic alloy such as the nickel (Ni) and cobalt (Co) alloy Phynox ®
  • the so shaped valve body 1 gives the valve a cylinder cage configuration.
  • the base of such a cylinder has a diametre of 6 to 14 millimetres and a height of 15 to 25 millimetres, the sizes being variable in connection with the veins whereinto the valve is to be positioned.
  • the ellipse-like turn, or main turn, 5 goes to assume an oblique position relative to the direction of the blood stream, indicated with 11 in figures 1 to 4, while the other two, circle-like turns 6, 6' will assume a position substantially perpendicular to it.
  • the function of the main, ellipse-like turn 5 is to constitute the support for anchoring a mobile plate or valving element 2.
  • the function of the two end turns 6, 6' is to keep the main turn 5 in the desired position and to impede a permanent collapse of the vein segment that contains the valve during low endoluminal pressure stages or after extrinsic compression, causing the redistension of the venous segment by means of the elastic reaction of the material which all the valve body is made up of.
  • the so configured support or valve body 1 is fit for being easily deformed, by applying a traction upon the two end turns 6, 6', so obtaining the movement indicated with the arrows 8 and 9 in figure 3 that causes a temporary and incomplete linearization, or decrease of its space occupation and increase of occupied length, of the valve. Under these conditions, the valve can be loaded into the carrying capsule 13 of the introducer catheter, to be disclosed hereinafter in connection with figures 5a to 5c.
  • valve is able to return to its original shape.
  • the support 1 is endowed with suitable hooks 7, arranged on one or more points of the three turns which it is made up of, having the aim of fixing into the wall of the vein after the release and the positioning of the valve, to prevent its accidental mobilization.
  • the mobile plate or sail valving element 2 is made up of a plastic material, as for instance expanded polytetrafluoroethylene or polyurethane or silicone, or of a homologous biologic material, as for instance pericardium, eventually treated with one of the processes in use with antithrombogenic aim, in thin plate, as for instance 0.1 to 0.3 millimetres.
  • the mobile plate is comprised of a sail, see figures 1 to 4.
  • the sail valving element is endowed with a check line 3 anchored to the turn 5 to this end, but it could also be endowed with an incorporated shaft (not shown).
  • the mobile plate 2 is freely floating within the venous lumen and is moved by the pressure gradient on the two surfaces of the same.
  • the plate In the stage of muscular systole, when the pressure on its distal surface is greater than that on its proximal surface, the plate lifts itself and assumes the opening position as in figure 3. With the valve in this position, the blood stream 11 is directed towards the heart.
  • the plate In the stage of muscular diastole, when the pressure of the blood upon the proximal surface is greater than that on the distal surface, the plate returns to the closure position 2, as in figure 1, and the backflow in distal direction is stopped. The return to the correct closure position is rendered easier by the presence of the reinforcement and anchoring element 3, which keeps the mobile plate in the most effective position for the whole operation of the valve.
  • Such an instrument is comprised of an introducer catheter, shown in figures 5a to 5c.
  • the introducer catheter after attracting the valve into the interior of the capsule by exploiting its flexibility features, is introduced into the venous lumen and allows the transport of the valve by intraluminal way up to the desired point and finally its release and definitive positioning.
  • the positioning takes place under the inspection of the surgeon's view or under fluoroscopic monitoring or other method.
  • the fixing of the valve into its correct position, in the interior of the vein can be achieved by means of direct suture points, applied from the exterior onto the venous wall and comprising in one or more points the valve body 1, or through the fixing into the venous wall of the proper hooks 7 on the body of the valve.
  • the valve still can be repositioned or removed and eventually substituted through percutaneous way, with a process analogous to that of introduction at a distance.

Claims (4)

  1. Une canule à utiliser dans un vaisseau sanguin, qui se place à l'intérieur de ce même vaisseau sanguin et entre en contact avec le flux sanguin ; qui est conçue de façon à être introduite et placée dans le vaisseau sanguin jusqu'à l'endroit désiré à l'aide d'un cathéter, le cathéter étant doté à son extrémité distale d'une capsule (13) destinée à la transporter à l'intérieur du vaisseau sanguin, et d'éléments (19 à 25) destinés à l'accrocher et à l'installer dans ladite capsule (13) et pour la libérer à l'endroit souhaité ;
    la canule comprend :
       un corps comportant un fil flexible courbé (1) ayant une élasticité et une plasticité qui le rendent résistant, auto-extensible et qui permettent de l'implanter n'importe où selon l'endroit souhaité ;
    où ledit fil est courbé de manière à former trois boucles au moins pour constituer un espace tubulaire limité, lesdites trois boucles incluant une boucle centrale (5) et deux extrémités (6, 6'), ladite boucle centrale (5) se trouvant à un angle par rapport auxdites extrémités (6, 6') ; et
       un élément tubulaire à cuspide simple (2) monté sur la boucle centrale (5).
  2. Une canule à utiliser dans un vaisseau sanguin selon la Revendication 1, caractérisée par le fait que la canule est dotée de crochets (7) destinés à fixer le fil à la paroi d'un vaisseau sanguin.
  3. Une canule à utiliser dans un vaisseau sanguin selon la Revendication 1, caractérisée par le fait que l'élément tubulaire à cuspide simple (2) est doté d'une ligne de contrôle (3) fixée à la boucle centrale (5).
  4. Une canule à utiliser dans un vaisseau sanguin selon la Revendication 1, caractérisée par le fait que le cathéter comporte en outre un ballon gonflable (14) destiné à provoquer l'occlusion du vaisseau sanguin.
EP93830500A 1993-12-14 1993-12-14 Valve d'implant percutané pour vaisseaux sanguins Expired - Lifetime EP0667133B1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
DE69330003T DE69330003T2 (de) 1993-12-14 1993-12-14 Perkutan implantierbares Ventil für Blutgefässe
ES93830500T ES2157918T3 (es) 1993-12-14 1993-12-14 Una valvula percutanea implantable para su uso en vasos sanguineos.
EP93830500A EP0667133B1 (fr) 1993-12-14 1993-12-14 Valve d'implant percutané pour vaisseaux sanguins
AT93830500T ATE199490T1 (de) 1993-12-14 1993-12-14 Perkutan implantierbares ventil für blutgefässe
US08/300,133 US5607465A (en) 1993-12-14 1994-09-02 Percutaneous implantable valve for the use in blood vessels

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP93830500A EP0667133B1 (fr) 1993-12-14 1993-12-14 Valve d'implant percutané pour vaisseaux sanguins

Publications (2)

Publication Number Publication Date
EP0667133A1 EP0667133A1 (fr) 1995-08-16
EP0667133B1 true EP0667133B1 (fr) 2001-03-07

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ID=8215275

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93830500A Expired - Lifetime EP0667133B1 (fr) 1993-12-14 1993-12-14 Valve d'implant percutané pour vaisseaux sanguins

Country Status (5)

Country Link
US (1) US5607465A (fr)
EP (1) EP0667133B1 (fr)
AT (1) ATE199490T1 (fr)
DE (1) DE69330003T2 (fr)
ES (1) ES2157918T3 (fr)

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US9421095B2 (en) 2008-03-27 2016-08-23 Genomnia Srl Valve prosthesis for implantation in body channels
US9668859B2 (en) 2011-08-05 2017-06-06 California Institute Of Technology Percutaneous heart valve delivery systems
US9744037B2 (en) 2013-03-15 2017-08-29 California Institute Of Technology Handle mechanism and functionality for repositioning and retrieval of transcatheter heart valves

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DE69330003T2 (de) 2001-10-04
ATE199490T1 (de) 2001-03-15
ES2157918T3 (es) 2001-09-01
EP0667133A1 (fr) 1995-08-16
US5607465A (en) 1997-03-04
DE69330003D1 (de) 2001-04-12

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